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Helmet continuous positive airway pressure versus high-flow nasal cannula in COVID-19 : a pragmatic randomised clinical trial (COVID HELMET)

Tverring, Jonas LU orcid ; Åkesson, Anna LU orcid and Nielsen, Niklas LU (2020) In Trials 21(1).
Abstract

Background: Patients with COVID-19 and hypoxaemia despite conventional low-flow oxygen therapy are often treated with high-flow nasal cannula (HFNC) in line with international guidelines. Oxygen delivery by helmet continuous positive airway pressure (CPAP) is a feasible option that enables a higher positive end-expiratory pressure (PEEP) and may theoretically reduce the need for intubation compared to HFNC but direct comparative evidence is lacking. Methods: We plan to perform an investigator-initiated, pragmatic, randomised trial at an intermediate-level COVID-19 cohort ward in Helsingborg Hospital, southern Sweden. We have estimated a required sample size of 120 patients randomised 1:1 to HFNC or Helmet CPAP to achieve 90% power to... (More)

Background: Patients with COVID-19 and hypoxaemia despite conventional low-flow oxygen therapy are often treated with high-flow nasal cannula (HFNC) in line with international guidelines. Oxygen delivery by helmet continuous positive airway pressure (CPAP) is a feasible option that enables a higher positive end-expiratory pressure (PEEP) and may theoretically reduce the need for intubation compared to HFNC but direct comparative evidence is lacking. Methods: We plan to perform an investigator-initiated, pragmatic, randomised trial at an intermediate-level COVID-19 cohort ward in Helsingborg Hospital, southern Sweden. We have estimated a required sample size of 120 patients randomised 1:1 to HFNC or Helmet CPAP to achieve 90% power to detect superiority at a 0.05 significance level regarding the primary outcome of ventilator free days (VFD) within 28 days using a Mann-Whitney U test. Patient recruitment is planned to being June 2020 and be completed in the first half of 2021. Discussion: We hypothesise that the use of Helmet CPAP will reduce the need for invasive mechanical ventilation compared to the use of HFNC without having a negative effect on survival. This could have important implications during the current COVID-19 epidemic. Trial registration: ClinicalTrials.gov NCT04395807. Registered on 20 May 2020.

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author
; and
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
COVID-19, Helmet CPAP, HFNC, Randomised controlled trial protocol, Ventilator-free days
in
Trials
volume
21
issue
1
article number
994
publisher
BioMed Central (BMC)
external identifiers
  • scopus:85097026244
  • pmid:33272319
ISSN
1745-6215
DOI
10.1186/s13063-020-04863-5
language
English
LU publication?
yes
id
70ac0c52-3324-4133-b526-a3dc7322410c
date added to LUP
2020-12-09 13:46:53
date last changed
2024-05-30 01:02:45
@article{70ac0c52-3324-4133-b526-a3dc7322410c,
  abstract     = {{<p>Background: Patients with COVID-19 and hypoxaemia despite conventional low-flow oxygen therapy are often treated with high-flow nasal cannula (HFNC) in line with international guidelines. Oxygen delivery by helmet continuous positive airway pressure (CPAP) is a feasible option that enables a higher positive end-expiratory pressure (PEEP) and may theoretically reduce the need for intubation compared to HFNC but direct comparative evidence is lacking. Methods: We plan to perform an investigator-initiated, pragmatic, randomised trial at an intermediate-level COVID-19 cohort ward in Helsingborg Hospital, southern Sweden. We have estimated a required sample size of 120 patients randomised 1:1 to HFNC or Helmet CPAP to achieve 90% power to detect superiority at a 0.05 significance level regarding the primary outcome of ventilator free days (VFD) within 28 days using a Mann-Whitney U test. Patient recruitment is planned to being June 2020 and be completed in the first half of 2021. Discussion: We hypothesise that the use of Helmet CPAP will reduce the need for invasive mechanical ventilation compared to the use of HFNC without having a negative effect on survival. This could have important implications during the current COVID-19 epidemic. Trial registration: ClinicalTrials.gov NCT04395807. Registered on 20 May 2020.</p>}},
  author       = {{Tverring, Jonas and Åkesson, Anna and Nielsen, Niklas}},
  issn         = {{1745-6215}},
  keywords     = {{COVID-19; Helmet CPAP; HFNC; Randomised controlled trial protocol; Ventilator-free days}},
  language     = {{eng}},
  number       = {{1}},
  publisher    = {{BioMed Central (BMC)}},
  series       = {{Trials}},
  title        = {{Helmet continuous positive airway pressure versus high-flow nasal cannula in COVID-19 : a pragmatic randomised clinical trial (COVID HELMET)}},
  url          = {{http://dx.doi.org/10.1186/s13063-020-04863-5}},
  doi          = {{10.1186/s13063-020-04863-5}},
  volume       = {{21}},
  year         = {{2020}},
}